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Regulatory action: Tavneos effectiveness questioned by EMA
The European Medicines Agency’s committee recommended withdrawing Amgen’s Tavneos (avacopan) from the European market, citing “incorrect and misleading” data provided during the marketing...
FDA approval expands competitive landscape for solid-tumor ADCs in TNBC
The FDA expanded Gilead’s Trodelvy label to allow use as a first-line treatment for triple-negative breast cancer regardless of PD-L1 status, strengthening the company’s position in the...
Clinical trial regulator path: Replimune’s RP1 gets resubmission decision timeline
Replimune secured an early August regulatory decision date for its third attempt at RP1, an oncolytic immunotherapy for advanced melanoma that has been rejected twice by the FDA. The FDA accepted...
New therapy signal: Intravesical CAR T targets MUC16 in bladder cancer model
Weill Cornell Medicine and Roswell Park Comprehensive Cancer Center reported preclinical results showing intravesical delivery of MUC16-targeting CAR T cells can control bladder tumors in mice....
Company launch: Bionyra raises to build next-gen inflammatory biologics platform
Bionyra Pharma emerged from stealth after raising an oversubscribed $165 million Series A to develop next-generation biologics for severe immunological and inflammatory diseases. The...
Branded drugmaker competition: Viridian’s veligrotug approved for thyroid eye disease
The FDA approved Viridian Therapeutics’ thyroid eye disease treatment veligrotug, to be marketed as Lumvoa, setting up direct competition with Amgen’s Tepezza. The approval adds a second...
Funding and M&A: Merck KGaA agrees to buy Bio-Techne for $11.3B
Merck KGaA agreed to acquire Bio-Techne in a deal valued at about $11.3 billion, expanding the acquirer’s life science tools, diagnostics, and multiomics offerings. The all-cash offer is $73 per...
Regulatory and rights: RQ Bio expands funding for long-acting flu antibody prophylaxis
RQ Bio secured an oversubscribed $115 million Series A to advance its single-dose long-acting antibody prophylaxis program for influenza in high-risk and immunocompromised populations. The lead...
Class action: Natera hit with lawsuit alleging misleading PGT-A genetic testing claims
Natera is facing a class action lawsuit alleging misleading marketing of its preimplantation genetic testing for aneuploidy (PGT-A) through its Spectrum PGT-A test. Plaintiffs Melissa Klein and...
Regulatory actions in rare disease and oncology
European regulators moved to pull Amgen’s Tavneos from the market after an assessment found the data submitted for the application “incorrect and misleading.” The EMA recommendation follows a...
Breakthrough immunotherapy targeting and delivery
Preclinical data from Weill Cornell Medicine and Roswell Park Comprehensive Cancer Center show that intravesical CAR T cells can control bladder tumors in mice. In a Journal of Experimental...
Funding and launch of new inflammatory disease biologics platform
Bionyra Pharma emerged from stealth after raising $165 million in an oversubscribed Series A to develop next-generation biologics for severe immunological and inflammatory diseases. The...
Cell and gene therapy business development and tech platforms
Moderna disclosed its first in vivo CAR-T program, aiming to move an autoimmune disease candidate into clinical development next year. The company framed the approach as an off-the-shelf...
High-stakes clinical and regulatory trial milestones in cardiometabolic disease
Ionis Pharmaceuticals secured a wider FDA approval for Tryngolza (olezarsen), expanding the therapy’s use into adults with severe hypertriglyceridemia. The approval follows phase III data...
Drug approvals that reshape oncology ADC competition
Gilead’s Trodelvy won an expanded FDA approval for first-line triple-negative breast cancer, enabling use regardless of PD-L1 status. The expanded label supports both monotherapy and combination...
AI in drug discovery—model validity, not model hype
A commentary piece directly challenges the idea that AI can compensate for preclinical models that don’t reflect patient tumor biology. The analysis argues that higher data volumes and better...
Evidence integrity in high-impact oncology publications
Nature Medicine retracted a high-profile Chinese lung cancer study after questions about protocol adherence and randomization patterns. The paper, known as Lungtime-C01, had claimed that giving...
Major merger to expand life-science tools and workflows
Merck KGaA agreed to acquire Bio-Techne in a deal valued at about $11.3 billion, its biggest acquisition in more than a decade. The transaction is structured around a $73 per share cash offer and...
CAR-T target discovery using human-in-the-loop AI
Researchers at the University of Pennsylvania presented an AI-enabled, human-in-the-loop framework to identify next-generation CAR T targets with multi-cancer potential. Published in Cell, the...
FDA approvals expanding immunotherapy use
The FDA expanded Gilead’s Trodelvy label into front-line triple-negative breast cancer (TNBC), giving TROP2 ADCs a new footing in first-line treatment. The update allows Trodelvy to be used in...